(144 days)
Drug Free Enterprises NextStp test cup is a convenient specimen collection cup and strip holder, which contains five (5) individual drug test strips for simultaneous detection of multiple drugs of abuse in human urine. The five test strips are individually encased within the wall of the device in separate chambers with no interconnections between each of the test strip. Up to nine (9) individual test strips are available for incorporation into the test device. The mine individual test strips include THC, cocaine, opiate, methamphesamine, pheneyclidine, amphesamine, barbiturates, benzodiazepines, and methadone. The cut-off concentration for each of the available test strip is listed below:
| THC | 11-nor-A 9-THC-9-COOH | 50 | ng/ml |
|---|---|---|---|
| COC | Benzoylecogine | 300 | ng/ml |
| OP' | Morphine | 2000 | ng/ml |
| MET | Methamphetamines | 1000 | ng/ml |
| PCP | Phencyclidine | 25 | ng/rnl |
| AMP | Amphetamines | 1000 | ng/ml |
| BAR | Secobarbital | 300 | ng/ml |
| BZO | Oxazepam | 300 | ng/ml |
| MTD | Methadone | 300 | ng/ml |
Drug Free Enterprises NexStp test cup is an in vitro diagnostic device, which provide for the visual qualitative results of up to nine drugs of abuse in human urine. The test is intended for professional and point of care use . This test device in not intended for over the counter sale to lay users.
The NexStp test cup provides only preliminary analytical test results. A more specific atternate chemical method must be used in order to obtained a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.
Drug Free Enterprises NextStp test cup is a convenient specimen collection cup and strip holder, which contains five (5) individual drug test strips for simultaneous detection of multiple drugs of abuse in human urine. The five test strips are individually encased within the wall of the device in separate chambers with no interconnections between each of the test strip. Up to nine (9) individual test strips are available for incorporation into the test device. The mine individual test strips include THC, cocaine, opiate, methamphesamine, pheneyclidine, amphesamine, barbiturates, benzodiazepines, and methadone.
The provided text is a 510(k) premarket notification decision letter from the FDA regarding the "Drug Free Enterprises NexStp Drug Check test cup." This document approves the device but does not contain a study that proves the device meets acceptance criteria.
Instead, it lists the "Indications for Use" and the cut-off concentrations for various drugs, which serve as the internal acceptance criteria for the device's performance against specific drug concentrations. The FDA's substantial equivalence determination is based on a comparison to legally marketed predicate devices, implying that their performance has been shown to be similar, but no specific study details are provided within this document.
Therefore, many of the requested details about a specific study cannot be extracted from this document because such a study is not described.
Here's what can be extracted from the provided text based on the nature of the device (an in vitro diagnostic test cup):
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the cut-off concentrations for each drug that the device is designed to detect. The device's "performance" is its ability to provide qualitative results (presence or absence) relative to these cut-off concentrations. The document states "Drug Free Enterprises NexStp test cup is a convenient specimen collection cup and strip holder, which contains five (5) individual drug test strips for simultaneous detection of multiple drugs of abuse in human urine." and "The NexStp test cup provides only preliminary analytical test results."
| Drug | Analyte | Cut-off Concentration (ng/ml) | Device Performance (Implicit from Preamble) |
|---|---|---|---|
| THC | 11-nor-A 9-THC-9-COOH | 50 | Detects at or above cut-off |
| COC (Cocaine) | Benzoylecogine | 300 | Detects at or above cut-off |
| OPI (Opiate) | Morphine | 2000 | Detects at or above cut-off |
| MET (Methamphetamine) | Methamphetamines | 1000 | Detects at or above cut-off |
| PCP (Phencyclidine) | Phencyclidine | 25 | Detects at or above cut-off |
| AMP (Amphetamines) | Amphetamines | 1000 | Detects at or above cut-off |
| BAR (Barbiturates) | Secobarbital | 300 | Detects at or above cut-off |
| BZO (Benzodiazepines) | Oxazepam | 300 | Detects at or above cut-off |
| MTD (Methadone) | Methadone | 300 | Detects at or above cut-off |
Note: The "Device Performance" column is inferred. For a 510(k) submission of an IVD, the device must demonstrate it can accurately detect the target analytes at or above these specified cut-off concentrations, and typically produce a negative result below the cut-off.
Information Not Available in the Provided Document:
The following information, which would typically be found in a detailed study report supporting a regulatory submission, is not present in this FDA decision letter:
- Sample size used for the test set and the data provenance: This document does not provide details on the number of samples used in any testing or their origin (e.g., country, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. For drug tests, ground truth is typically established by instrumental analysis (e.g., GC/MS), not human experts interpreting test results.
- Adjudication method: Not applicable/not specified, as ground truth for drug testing is instrumental.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This is not relevant for this type of in vitro diagnostic device (a qualitative, visual test strip). There is no "human reader improvement with AI" as it's not an AI-powered image interpretation device.
- Standalone (algorithm only without human-in-the-loop performance): This is an in vitro diagnostic device, not an algorithm. Its performance is inherent in the chemical reactions on the test strips. The interpretation is visual, by a human, but there's no "algorithm only" performance separate from the physical strips.
- The type of ground truth used: While not explicitly stated, for drug tests, the "gold standard" or ground truth is typically established through Gas Chromatography/Mass Spectrometry (GC/MS), as mentioned in the document: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."
- Sample size for the training set: Not applicable and not mentioned, as this is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable and not mentioned.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).